Fischer Analysen Instrumente Gmbh

CLOSEOUT LETTER Fischer Analysen Instrumente Gmbh MARCS-CMS 650388 — July 08, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Dr. Martin Schaich Recipient Title Managing Director Fischer Analysen Instrumente Gmbh Brahestr. 25-27 04347 Leipzig, Saxony Germany Martin.Schaich@fan-gmbh.de Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Dr. Martin Schaich: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS# 650388, dated February 3, 2023). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Courtney H. Lias, Ph.D. Acting Director OHT7: Office of In Vitro Diagnostic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health CC: US AGENT: Philip Ross Gulf Coast Scientific, Inc. / ARJ Medical, Inc. 209 State Street E. Oldsmar, FL US 34677 Email: PRoss@Gulfcoastscientific.com Content current as of: 07/15/2024 Regulated Product(s) Medical Devices